A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorKessler Foundation
About this trial
This study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-59 years old
recent traumatic SCI (approximately 6 months post-injury)
Disqualifiers
no other significant neurological, psychiatric or substance use history
no significantly impairing visual disturbance
Trial design
Design model
Parallel
Treatments tested in this trial
game-like computerized activities
BehavioralExperimental
Placebo
Behavioralgame-like computerized activities
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Useful Field of View (UFOV)
computerized processing speed task
Time frame
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)2
Letter & Pattern Comparison (LPC)
processing speed task, using both letter and pattern strings
Time frame
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)3
Symbol Digit Modalities Test (SDMT)
processing speed task, matching numbers to symbols using a key
Time frame
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)Secondary outcomes
1
Spinal Cord Injury Quality of Life scales
self-reported instruments of quality of life after SCI
Time frame
baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)Sponsors and contacts
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Source ClinicalTrials.gov